Kornimate/medical-research-clean huggingface dataset:
project first - financial incentives to reduce substance use and improve treatment

Conditions: HIV; Opiate Dependence

Summary: this study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving hiv viral load suppression). in a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in hiv-infected drug users.

using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (performance feedback) on hiv viral load suppression. the investigators will enroll 202 opioid-dependent hiv-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor hiv treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. the contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. participants will be followed for 28 weeks, with research visits occurring twice weekly during the baseline period (weeks 1-4) and intervention period (weeks 5-20), then every two weeks during the post-intervention period (weeks 21-28). data sources will include blood tests (viral load and cd4 count), urine toxicology tests, questionnaires, pill counts, and medical records. the primary outcome will be change in hiv viral load, and secondary outcomes will include cd4 count, antiretroviral adherence, and abstinence.

Eligibility criteria:
inclusion criteria: * at least 18 years old * english or spanish fluency * hiv-infected * currently taking highly active antiretroviral therapy * a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder * urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period * detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months * self-reported adherence to haart \<100% exclusion criteria: * inability to give informed consent * inability to follow the research protocol (e.g., visits twice weekly) * frequent hospitalizations (\>2) in the prior 6 months * currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month

Keywords: hiv opiate dependence opiate replacement therapy cocaine-related disorders risk reduction behavior medication adherence motivation
real world use of azacitidine and venetoclax in acute myeloid leukemia in frontline and relapse/refractory

Conditions: Acute Myeloid Leukemia

Summary: azacytidine and venetoclax combination regimen (aza/ven) is the standard of care in frontline acute myeloid leukemia (aml) settings for unfit to intensive chemotherapy patients. aza/ven combination regiment was approved in france in 2021 but was already used in outlabel fashion since 2019. however, aza/ven is also associated with an increased hematological toxicity compared to azacytidine alone. in this context, alternative aza/ven regimens emerged progressively based on each physician experience and local procedures. moreover, aza/ven is also recognized as a valuable therapeutic option in relapse/refractory settings. in this multicentric study, the investigators aimed to evaluate the efficacy and safety of various aza/ven regimen in frontline and relapse/refractory (r/r) patients diagnosed with aml in real life setting. the investigators will retrospectively analyze clinical outcome of patients from 11 different french centers (saint-etienne, clermont-ferrand, lyon (hopital lyon sud, centre léon bérard), vichy, annecy, chambery, valence, bourgoin-jallieu, grenoble, roanne) in auvergne rhône alpes (aura) region, between january 2019 and december 2023. composite complete remission was defined as in viale-a trial. measurable residual disease (mrd) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for npm1 by rt-qpcr.


Eligibility criteria:
inclusion criteria: * \>18 years old * acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or mrd relapse. * receiving aza/ven combination regimen exclusion criteria: * another ven combination chemotherapy * aza/ven initiation prior january 2019 and after december 2023 * opposition to the study

Keywords: acute myeloid leukemia azacitdine venetoclax mrd
bowel preparation before rectal cancer surgery

Conditions: Rectal Cancer

Summary: traditionally bowel preparation before surgery of rectal cancer could be troublesome for patients especially for patients with kidney and cardio- vascular diseases, where salt and electrolyte balance can be a problem. cleaning the bowel without complications for the patient is one of the aims for this study. the other aim is to see if patient nutritional status improves with nutritional drinks as a complement to food intake 4-6 weeks before surgery.

in our institution, patients undergoing surgery for cancer in the rectum are often prepared with energy drinks in order to receive a higher energy level before the operation. as a result of this the patients often avoid nausea and have a better intestinal function after surgery and less complications. we think that this treatment has worked well on the patients but no scientific studies have been done on these patients. as a complementary result of the treatment with nutritional drinks we have found that the colon is empty already after a short time of treatment. the actual study's purpose is to find out if rectal cancer surgery can be performed without traditionally bowel preparation. nutritional drinks are to be used instead of traditional bowel preparation. patients are randomized into two groups, stratification for stricture, malnutrition and laparoscopic surgery and each group should either bee treated with traditional bowel preparation, laxabon® (a) or nutritional drinks, fresubin energy drink (b) before surgery. patients in subgroup b take nutritional drinks seven days before surgery instead of ordinary food. bowel purity degree is measured peroperatively. the secondary aim is to see if malnutrition can be improved with nutritional drinks as a complement to ordinary food intake before surgery. for four to six weeks before surgery 50 % or more of the caloric need is substituted with nutritional drinks in subgroup b (fresubin energy drink 15-30 kcal/kg\*day). subgroup a only eats ordinary food throughout the same period, before surgery. bowel purity degree, physiological functions, and body mass index are measured in all four groups before and after surgery. all patients in the study keep records of physical activity daily, and food diary twice a week. complications are registered. blood samples for hormones and electrolytes are taken before and after surgery.

Eligibility criteria:
inclusion criteria: * rectal cancer * men * women * age 18-90 years exclusion criteria: * acute ileus * seriously dementia * metastatic disease

Keywords: patients with rectal cancer undergoing surgery bowel purity degree bowel preparation rectal cancer nutritional status complications with traditional bowel preparation complications physiological status
effect of calcium silicate-based root canal medicament after retreatment

Conditions: Antibacterial Agents; Postoperative Dental Pain; Antifungal Agents

Summary: calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. however, the antimicrobial effect of calcium hydroxide is limited. a new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments. the aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.

sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament). after the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. the root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. the selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week. at the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. the root canal treatments of the patients were then completed. the antibacterial and antifungal effects of the medicaments were evaluated using pcr, and the patients' postoperative pain levels were recorded using follow-up forms.

Eligibility criteria:
inclusion criteria: * healthy patients with aged between 18-60. * incisor, canine, and premolar teeth that had previously undergone root canal treatment * incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis * teeth with only 1 root canal * the patients had not used any antibiotics for 3 months before treatment exclusion criteria: * the presence of a root fracture * teeth with any swelling * ankyloses, * periodontal pockets deeper than 4 mm. * teeth which a rubber dam could not be performed * patients with allergy to ibuprofen or ciprofloxacin were also excluded.

Keywords: calcium silicate based root canal medicament calcium hydroxide based root canal medicament bacterial load antibacterial effect antifungal effect postoperative pain
an observational study of the ethnic impact of patients undergoing second (2nd) line treatment for non-small cell lung cancer using pemetrexed

Conditions: Lung Neoplasms

Summary: this large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (nsclc) in a routine medical care setting.

this is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (caucasian, african-americans, asian-americans, and hispanics) on patients being treated for 2nd line advanced nsclc with pemetrexed given in routine clinical practice. data will be collected on disease control rate by pemetrexed as defined by response rate (rr) (complete response (cr) + partial response (pr)), stable disease (sd) and toxicities. in addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. to meet the study goals, a total of 400 caucasians, 200 african- americans, 200 asian-americans, and 200 hispanics will be accrued to this study.

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer (nsclc) (any histologic type) * stage iiib or iv disease * should have had 1 line of chemotherapy for metastatic disease * adequate hematologic, hepatic and renal function * measurable or evaluable disease exclusion criteria: * pregnant or lactating females
act01 in combination with comp01-04 in patients with actinic keratosis

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine whether or not act01 is effective and tolerable alone or when used in combination with comp01, comp02, comp03 or comp04 in patients with facial and/or scalp keratosis.


Eligibility criteria:
inclusion criteria: 1. presence of actinic keratosis lesions on the face and/or scalp within a 25 cm2 contiguous area containing at least four lesions that are non-hypertrophic and non-hyperkeratotic and not larger than 6 mm in longest diameter. 2. age 30-85 years, inclusive. 3. good general health as determined by investigator and supported by medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse). exclusion criteria: 1. severe, uncontrolled auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, pulmonary or renal disease. 2. dermatologic conditions if present on the face such as acne, atopic dermatitis, seborrheic dermatitis, eczema, rosacea, or albinism. 3. application of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) puva (psoralen plus ultraviolet a) therapy, or 5) uvb therapy to the intended treatment area within 180 days prior to the baseline visit. 4. use of sun lamps or sun tanning beds or booths during the 14 days prior to the baseline visit.
translating habituation research to interventions for pediatric obesity

Conditions: Pediatric Obesity; Habituation

Summary: the purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

habituation is one factor that may be related to excess energy intake. research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers. habituation is a basic form of learning that is observed in many response systems. we believe that habituation is an important process that mediates food regulation during a meal and across meals. however, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity. in the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation. the second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment. the third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.

Eligibility criteria:
inclusion criteria: * children ages 8-12 years of age * at or above 85th bmi percentile * children must eat almost all meals with the exception of school lunch with the family. * overweight parent exclusion criteria: * children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods. * families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders. * the parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes. * children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.
study in healthy volunteers to investigate the effects of rifampin on the pharmacokinetics of nktr-118

Conditions: Drug Induced Constipation

Summary: study in healthy volunteers to investigate the effects of rifampin on the pharmacokinetics of nktr-118.

an open-label, fixed-sequence, 3-period, 3-treatment, crossover study to assess the effects of rifampin on pharmacokinetics of nktr-118 in healthy subjects.

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study-specific procedures. * male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture. * female volunteers must have a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential. * male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the ip. the female partner should use contraception during this period. * volunteers must have a bmi between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg. exclusion criteria: * any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, or major physical impairment), as judged by the investigator. * any clinically significant illness, medical/surgical procedure or trauma, in the opinion of the investigator, within 4 weeks of the first administration of ip. * any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the investigator. * significant orthostatic reaction at enrollment as judged by the investigator. * abnormal vital signs, after 10 minutes supine rest as defined in protocol.

Keywords: phase 1 healthy male and female volunteers drug-drug interaction pharmacokinetics nktr-118 bioavailability plasma auc and cmax plasma auc0-t and t1/2λz and tmax
a phase ib dose escalation study of the combination of lee011 with letrozole and dose expansion of lee011 with hormonal therapy for the treatment of pre-(with goserelin) and postmenopausal women with hormone receptor positive, her2-negative, advanced breast cancer

Conditions: Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Summary: the purpose of the phase ib is to: 1. determine the recommended dose of lee011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in asian non-japanese patients 2. determine the recommended dose of lee011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in japanese patients 3. evaluate the safety and anti-tumor activity of lee011 at the rp2d established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in japanese patients.


Eligibility criteria:
inclusion criteria: * women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy). * patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer * patient has her2-negative breast cancer * patient has adequate bone marrow and organ function exclusion criteria: * patient who received any cdk4/6 inhibitor. * patient has a known hypersensitivity to any of the excipients of lee011 or letrozole * patients with inflammatory breast cancer. * patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer * patient is currently using other anti-cancer therapy * patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects. * patient who has received radiotherapy ≤ 4 weeks * patient has a concurrent malignancy or malignancy within 3 years * patient has metastases to the central nervous system (cns). * patient has a known history of hiv infection other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced breast cancer hormone receptor positive her2-negative lee011, letrozole tamoxifen fulvestrant postmenopausal asian women pre and postmenopausal japanese women
effectiveness of micardis® (telmisartan) on blood pressure control and quality of live in patients with essential hypertension

Conditions: Hypertension

Summary: study to assess the effect of telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.


Eligibility criteria:
inclusion criteria: * patients with stage i essential hypertension (diastolic blood pressure 90-99 mmhg, and/or systolic blood pressure 140-159 mmhg) * signed informed consent form exclusion criteria: - females of childbearing potential
meclofenamate in subjects with recurrent or progressive brain metastasis from solid tumor primary

Conditions: Recurrent Brain Metastases; Progressive Brain Metastases

Summary: cancer that has spread to the brain, or brain metastasis, is difficult to treat. meclofenamate is a drug which has been shown to reduce brain metastasis growth in the laboratory. this medicine has been used in the past to treat pain. but, in this study, it will be used to prevent new brain metastasis. this is the first time that meclofenamate will be used in patients with brain metastasis. this is a pilot study which means that the purpose of this study is to determine if a larger clinical trial of meclofenamate is possible in patients with brain metastasis. this study also aims to find out what effects, good and/or bad meclofenamate has on the patient and the cancer that has spread to the brain. the investigators also want to learn more about potential effects that this drug may have in the digestive system.


Eligibility criteria:
inclusion criteria: * age 18-80 * kps ≥ 60 * at least one recurrent or progressive brain metastasis (es) from any solid primary tumor that is visible on mri as assessed by the patient's treating physician. * recurrence may occur after any treatment: recurrence after whole-brain radiation, stereotactic radiosurgery, surgical resection, systemic chemotherapy are all acceptable. * there is no limit on the number of brain metastases. * surgical resection or srs to other recurrent lesions in the same patient are acceptable, provided one recurrent lesion remains untreated. * systemic disease must be well-controlled or ned in the opinion of the patient's primary oncologist. exclusion criteria: * inability to get brain mri +/- contrast * progressive systemic disease * known leptomeningeal metastases * primary brain tumor * active intracranial hemorrhage * surgery less than two weeks before enrollment * gi hemorrhage (active or in recent 6 months) * concurrent anti-platelet therapy * concurrent anti-coagulation therapy * active bleeding diathesis * platelet count ≤ 70,000/mm3 * international normalized ratio (inr) \> 1.6 and a partial thromboplastin time (ptt) \> 40 seconds * serum creatinine \>2 mg/dl or crcl \<30ml/min * ast or alt \> 200 u/l * hemoglobin \<8 g/dl * allergy to meclofenamate or other nsaid * inability to tolerate po dosing * steroid dose increased in the most recent two weeks. * pregnancy * cardiac arrhythmia requiring medical management and/or pacemaker. * known congestive heart failure requiring medical management

Keywords: meclofenamate 15-068
european study of poba versus cotavance(r) paclitaxel coated balloon for the treatment of infrapopliteal lesions in critical limb ischemia (euro canal)

Conditions: PAD; Infrapopliteal Lesions

Summary: to evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the cotavance paclitaxel-coated balloon vs. those who received poba only.


Eligibility criteria:
inclusion criteria: - subjects with cli exclusion criteria: * participation in another research trial * medical conditions the study doctor will assess